Kornimate/medical-research-clean huggingface dataset:
benzodiazepine taper with cognitive behavioral therapy in patients using prescription opioids

Conditions: Anxiety Disorders

Summary: taking prescription opioids for pain together with benzodiazepines for the treatment of anxiety disorders is not recommended by the u.s. food and drug administration (fda) because of the elevated risk of serious complications, including fatal overdose. however, this concurrent prescription use continues to be prevalent, likely due to the high comorbidity between pain and anxiety disorders. efforts are urgently needed to reduce benzodiazepine use among patients taking opioids. cognitive behavioral therapy (cbt) is a first-line treatment for anxiety disorders, and represents a safer and more effective treatment for anxiety disorders compared to benzodiazepines. the proposed study aims to make minor adaptations to a cbt protocol to facilitate benzodiazepine tapering and to then conduct a 2-arm randomized clinical trial with primary care patients who receive benzodiazepine and opioid prescriptions. participants will be randomized to receive a telehealth-delivered intervention consisting of a gentle, 12-week benzodiazepine taper (bzt) with either cbt or a health education control (he). participants will be assessed at baseline, several points throughout treatment, at post-treatment, and at a 2-month follow-up assessment on benzodiazepine use, opioid use, and anxiety symptoms. should cbt + bzt outperform he + bzt, this intervention could make a significant impact by reducing major consequences of concurrent use of opioids and benzodiazepines, including mortality.


Eligibility criteria:
inclusion criteria: * taking prescribed bzs for at least 3 months prior to baseline and have a positive uds for bzs at baseline * currently experiencing significant distress or impairment due to their anxiety symptoms (i.e., score ≥ 6 on the oasis during screening * have been prescribed opioids for at least 3 months for pain management and have a positive uds for prescribed opioids at baseline * are between 18-85 years old * are fluent in english * have access to a digital device with internet access for telehealth * are willing to reduce bz use. exclusion criteria: * pregnancy * psychiatric symptoms requiring a higher level of care (i.e., severe suicidality, manic or psychotic symptoms not stabilized on medication) * presence of any sud other than tobacco use disorder, oud (co-occurring with pain condition) or sedative/hypnotic use disorder) * medical conditions that require ongoing treatment with benzodiazepines (e.g., certain seizure disorders) * use of drugs other than bzs and opioids in the past 30 days (as indicated by uds and self-report), with the exception of intermittent cannabis use (not meeting criteria for cud) and use of alcohol above at-risk drinking cutoffs per us dietary guidelines * marked cognitive impairment.
the effect of subcutaneous and intraperitoneal anesthesia on post laparoscopic pain

Conditions: Varicocele; Postoperative Pain

Summary: aim of this study is to examine the effects of subcutaneously applied local anesthetics at trocar site in combination with intraoperative intraperitoneal analgesia on duration and character of pain in pediatric patients undergoing laparoscopic varicocelectomy.


Eligibility criteria:
inclusion criteria: * pediatric patients with varicocele who underwent laparoscopic varicocelectomy * pediatric patients whose parents or guardians gave informed consent exclusion criteria: * patients who received open or microsurgical varicocelectomy * pediatric patients who underwent conversion to open procedure * pediatric patients with chronic, metabolic and endocrine diseases * pediatric patients with systemic infections
glycerin suppositories used prophylactically in premature infants (supp): a pilot randomized placebo-controlled trial

Conditions: Feeding Intolerance in Premature Infants

Summary: all premature babies have problems with feeding and nutrition. some can develop a life-threatening bowel infection necrotizing enterocolitis. this can result in the need for emergency surgery, loss of bowel, lifelong feeding problems, and death. giving premature babies glycerin suppositories may be one way to stimulate the digestive tract and help prevent these problems. to see if this treatment works, the investigators need to study hundreds of premature babies in a large trial involving multiple hospitals. the purpose of this project is to carry out a small study first and make sure that the larger trial is feasible. the investigators will invite approximately 30 premature babies from the neonatal intensive care unit at mcmaster university medical centre to participate in this study over a 6-month period. the investigators will focus on feasibility issues, including cost, safety, and rate of participation. this will allow us to rigorously test our study protocol and lay the groundwork for the larger study involving multiple hospitals.


Eligibility criteria:
inclusion criteria: * gestational age 24-32 weeks or * birth weight 500-1500 grams exclusion criteria: * congenital gastrointestinal anomalies * surgery within 48 hours of birth * culture-proven sepsis\* * vasopressors within 6 hours of first intervention * nitric oxide * duct-dependent congenital heart defect requiring prostaglandins * suspected coagulopathy (mucosal bleeding from any orifice) * confirmed coagulopathy (any one of the following): * international normalized ratio greater than 1.4 * partial thromboplastin time greater than 39 seconds * fibrinogen less than 1.00 grams/liter * thrombocytopenia (platelet count less than 100 x 10\^9/liter)\*\* * neutropenia (absolute neutrophil count less than 0.5 x 10\^9/liter) * complete meconium evacuation (2 normal bowel movements) within 48 hours of life * parent or legal guardian unable to understand english note: \* c-reactive protein is not an exclusion criteria \*\* indomethacin alone is not an exclusion criteria

Keywords: glycerin suppositories enteral nutrition enterocolitis, necrotizing infant, premature meconium
single ascending dose of amg 609 in participants with non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease

Summary: this study aims to assess the safety and tolerability of amg 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (nafld).


Eligibility criteria:
* inclusion criteria * men and women age ≥ 18 to ≤ 70 years of age at the time of signing the informed consent * body mass index (bmi) of ≥ 27 kg/m2 to ≤ 45.0 kg/m2 * liver steatosis, measured by mri-pdff, greater than 8% * exclusion criteria * evidence of other liver disease (eg, viral hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune chronic hepatitis, wilson's disease, alpha-1 anti-trypsin deficiency, haemochromatosis, drug-induced liver injury, bile duct obstruction, known or suspected hepatocellular carcinoma). * significantly elevated lfts (more than 1.5x uln) * uncontrolled diabetes (hgba1c \> 9%) or uncontrolled hypertension. * history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers occurring more than 5 years prior to randomization or 3 years prior to randomization for basal cell carcinoma. * females of reproductive potential.

Keywords: single ascending dose nafld amg 609
phase 1/1b/2 study of oral pmd-026 in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to test the safety and tolerability of pmd-026 in patients with metastatic breast cancer. pmd-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer.

combination with fulvestrant (part 3): this study will prospectively enroll rsk2+, hr+, and human epidermal growth factor receptor 2 negative (her2-) patients to evaluate pmd-026 in combination with a standard dose and schedule of fulvestrant. fulvestrant will be dosed per the package insert in combination with pmd-026 at the rp2d determined in the monotherapy phase of the study. up to 20 patients will be enrolled with locally advanced or metastatic hr+/her2- breast cancer previously treated with a cdk4/6 inhibitor in combination with endocrine therapy.

Eligibility criteria:
inclusion criteria, combination with fulvestrant (part 3): * rsk2 positive from available archival or fresh tumor tissue (ffpe). * histologically or cytologically diagnosed hr+, her2- * diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amendable to resection or radiation with curative intent or metastatic disease not amendable to curative therapy * must be appropriate candidates for endocrine therapy * previously received at least 1 line of endocrine therapy for mbc or had recurrence while on adjuvant endocrine therapy for locally advanced breast cancer * discontinued endocrine therapy at least 15 days prior to first dose of pmd-026 * at least 1 measurable target lesion as defined by recist v1.1 * progression on or after treatment with a cdk4/6 inhibitor in combination with endocrine therapy inhibitor in the locally advanced or metastatic setting * adequate hematologic, hepatic, and renal function as assessed by laboratory parameters * toxicity related to prior therapy resolved to at least grade 1 (alopecia excepted) or to at least grade 2 with prior approval of the medical monitor exclusion criteria, combination with fulvestrant (part 3): * ≤14 days from prior chemotherapy, biological or investigational therapy * prior fulvestrant in the locally advanced or metastatic setting * presence of visceral crisis or uncontrolled visceral disease for which chemotherapy would be indicated * central nervous system metastases, unless appropriately treated and neurologically stable * history of leptomeningeal metastases * active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy * known hepatitis b or hepatitis c infection * known hiv-positive with cd4+ cell counts \<350 cells/μl * known hiv-positive with a history of an aids-defining opportunistic infection * history of clinically significant cardiovascular abnormalities, including qtcf interval \>460 msec (using fridericia's formula)

Keywords: invasive breast cancer pr-negative breast cancer her2-negative breast cancer breast cancer breast malignancy breast malignancies metastatic breast cancer advanced breast cancer solid tumor late stage breast cancer/late-stage breast cancer
effect of acupuncture on incomplete fallopian tube obstructive infertility: study protocol for trial

Conditions: Female Infertility Due to Occlusion of Fallopian Tube

Summary: acupuncture is one of the traditional chinese practices widely used in china for more than 3000 years. in recent years, the use of acupuncture within infertility has gained popularity all over the world, but there is no research describing the use of acupuncture in infertility of incompletely obstructive fallopian tube. in this paper, we present a research design evaluating the effects of acupuncture on incomplete fallopian tube obstructive infertility. this is a randomized, control acupuncture and signal-blind trial. a total of 120 patients will be enrolled in this study and will be randomized into two groups. true acupuncture plus hydrotubation or control acupuncture plus hydrotubation will be performed for 12 weeks. the purpose of this paper is to evaluate the additional value of acupuncture on the tubal patency rate and pregnancy rate beyond hydrotubation ,therefore to guide clinical.


Eligibility criteria:
inclusion criteria: * i.patients between 22 and 42 years of age with infertility ii.diagnosis of incomplete fallopian tube obstruction based on one of the following conditions: a. tubal patency test: hydrotubation , hysterosalpingography (hsg) or hysterosonosalpingography (hss) shows incomplete bilateral fallopian tube obstruction b. hysteroscopy: hysteroscopic tubal cannulation hydrotubation proves bilateral tube incompletely patent. c. laparoscopy: incomplete bilateral tubal obstruction can be displayed by the methylene blue solution through the tubes iii.other relative treatments are not carried out within two weeks iv.willing to cooperate with us v. mean infertility time is 1-5 years. exclusion criteria: * i.allergic constitution or be allergic to diatrizoate or a variety of drugs ii.the infertility is not leaded by tubal obstruction ,such as congenital physiological defects or malformation, genetic factors, immune factors and endocrine factors iii.diagnosed with uterine lesions by auxiliary examinations (endometriosis ,adenomyosis , hysteromyoma or cancer and so on ) and infertility caused by tubal tuberculosis iv. infertility factor in their male partner v.people with serious primary diseases of cardiovascular, liver, kidney and hematopoietic systems ,patients with mental illness vi.unable to judge the therapeutic efficacy or incomplete information vii.complete bilateral tubal obstruction viii.bilateral tubes patent ix.not willing to give written consent to the study x. people who are pregnant xi.people with acute infection .

Keywords: hydrotubation incomplete fallopian tube obstructive infertility acupuncture
to demonstrate the relative bioequivalence of lisinopril 1 x 40 mg tablet under fasting and fed

Conditions: Hypertension

Summary: to demonstrate the relative bioequivalence of lisinopril 1 x 40 mg tablet under fasting and fed.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.
effects contrast on platelet activity, thrombosis and fibrinolysis in patients undergoing coronary angiography

Conditions: Coronary Artery Disease

Summary: the aim of this study is to determine how two different types of iodinated contrast media (cm) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific markers of thrombogenesis and platelet function in patients undergoing coronary angiography, and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary intervention (pci), affects any contrast-related changes in thrombogenesis and platelet function.


Eligibility criteria:
inclusion criteria: * patients must be more than 18 years of age * referred for coronary angiography and on dual anti-platelet therapy (aspirin and clopidogrel). exclusion criteria: * on warfarin * on low molecular weight heparin within 12 hours of coronary angiography or unfractionated heparin with activated clotting time \>150 at time of procedure -on cilostazol * on persantine * on non- steroidal anti-inflammatory medications (ibuprofen/motrin/advil, naproxen/aleve, indomethacin, sulindac, etodolac, diclofenac, celecoxib) within 72 hours of procedure * on prasugrel (not an exclusion criteria for st-segment elevation myocardial infarction registry * undergoing coronary angiography via radial access * undergoing planned diagnostic coronary angiography only * unable to tolerate dual anti-platelet therapy * with known allergy to cm * received cm within 24 hours of coronary angiography * on dialysis * do not consent or are unable to give consent * are participating in another competing study.

Keywords: coronary angiography percutaneous coronary intervention contrast media platelet activity thrombin generation fibrinolysis
clinical evaluation of biofinity multifocal compared with air optix aqua multifocal and with purevision multifocal

Conditions: Presbyopia

Summary: this is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the biofinity® multifocal lens and respectively the air optix® aqua multifocal lens (lenses allocated on a ratio of 1/0.5) and the purevision® multifocal lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients.

this is a prospective, multi-centre, randomised, single-blind, cross-over study to compare the biofinity® multifocal lens and respectively the air optix® aqua multifocal lens (lenses allocated on a ratio of 1/0.5) and the purevision® multifocal lens (lenses allocated on a ratio of 1/0.5), in presbyopic patients. each subject will have 5 visits with the investigator: * (v1) an inclusion visit during which the first pair of lenses are fitted; * (v2) an optimization visit after 7 to 9 days of wearing the first lens; * (v3) an evaluation visit after an additional 10 to 15 days of wearing the first lens (17 to 24 days) and at which time the second pair of lenses are fitted; * (v4, v5) visits are conducted as in v 2 and v3 with the second pair of lenses.

Eligibility criteria:
inclusion criteria: * male and female patients, aged 18 years or older * patients with proven presbyopia * patients who do not wear contact lenses or who wore spherical lenses before being included in the study * myopic patients whose spherical equivalent is less than or equal to 9.00 d (or a "lens" power less than or equal to -8,00 d) or hypermetropic patients whose spherical equivalent is less than or equal to +5.50 d (or a "lens" power less than or equal to +6,00 d) or emmetropic patients for distance vision (plan) * patient able to fill in a diary without help * patients who gave their informed consent to take part in the study exclusion criteria: * patients with a contra-indication for wearing contact lenses * patients suffering from any ocular pathology that might interfere with the evaluation of the lenses * patients wearing multifocal lenses or spherical lenses for monovision before being included in the study * astigmatic patients whose cylinder is more than 0.75 d
safety and efficacy of gs-4774 for the treatment of chronic hepatitis b

Conditions: Chronic HBV Infection

Summary: the primary objectives of this study are to evaluate the safety and efficacy of gs-4774 in adults with chronic hepatitis b (chb) viral infection who have been virally suppressed with an oral antiviral (oav) medication.


Eligibility criteria:
key inclusion criteria: * ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * currently taking an approved hbv oral antiviral medication * documented evidence of chronic hbv infection (eg, hbsag positive for more than 6 months) * virally-suppressed (hbv dna below the lower limit of quantification (lloq) for ≥ 1 year) key exclusion criteria: * cirrhosis * inadequate liver function * co-infection with hepatitic c virus (hcv), hiv or hepatitic d virus (hdv) * evidence of hepatocellular carcinoma * significant cardiovascular, pulmonary, or neurological disease * females who are pregnant or may wish to become pregnant during the study * received solid organ or bone marrow transplant * use of another investigational agents within 3 months of screening * current alcohol or substance abuse judged by the investigator to potentially interfere with compliance * history of demyelinating disease (guillain-barre), bell's palsy, crohn's disease ulcerative colitis, autoimmune disease * known hypersensitivity to study drug, metabolites or formulation excipients * malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). participants under evaluation for possible malignancy are not eligible. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hepatitis b (hbv) oral antiviral (oav) gs-4774
comparative study on changes in anterior chamber cytokines, oxidative stress, and pupil size after lensx and z8 femtosecond lasers

Conditions: Cataract

Summary: femtosecond laser-assisted cataract surgery is rapidly gaining popularity. among the 5 femtosecond laser platforms available at present for cataract surgery, the femto ldv z8 (ziemer ophthalmic systems ag) is a high-frequency system and delivers energy pulses in nanojoule levels, while lensx platform (lensx, alcon laboratories, inc.) used a high-energy laser system. in femtosecond laser-assisted cataract surgery, the laser pretreatment is associated with breakdown of blood-aqueous barrier (bab) associated with increased aqueous total prostaglandin, cytokines and oxygen-free radicals concentration. the prostaglandin rise immediately after laser pretreatment is further thought to be the causative factor for the intraoperative miosis in femtosecond laser-assisted cataract surgery. however, the analysis of anterior chamber inflammatory factors, oxidative stress, and pupil size after femtosecond laser-assisted cataract surgery between different laser platforms has not been investigated in clinical studies. understanding the cytokine and chemokine changes related to the laser pretreatment provides better insight into the inflammatory response in femtosecond laser-assisted cataract surgery.


Eligibility criteria:
inclusion criteria: age related cataracts over 50 years old, nuclear grades ii-iii exclusion criteria: * eye diseases: glaucoma, uveitis * systemic diseases: autoimmune diseases such as diabetes and rheumatism ③ intraoperative complications: ④ medication history: over 1 month before surgery, systemic or local hormones, nasids ⑤ history of eye surgery (including yag laser and fundus laser), trauma

Keywords: cataract; femtosecond laser; cytokines; oxidative stress; miosis;
effect of sildenafil citrate on uteri- placental perfusion, doppler indices in growth restricted fetuses

Conditions: Pregnancy Complication

Summary: to detect the effect of sildenafil citrate on doppler parameters in fetuses suffering from growth restriction to support its use later as prolonged therapy in those pregnancies at higher risk for such complication.

participants were randomized in 1:1 ratio into one of the following drug regime: group (i): "sildenafil citrate group" this group consisted of 22 women who received single oral dose of 50 mg sildenafil citrate. group (ii): "placebo group" this group consisted of 22 women who received single oral dose of placebo. all participants were evaluated by ultrasound once they admitted and again after 2-hours following administration of either of the treatment tablets. one sonographer was allocated to evaluate all mothers included in the study.

Eligibility criteria:
inclusion criteria: patients were admitted to the study based on the following inclusion criteria: 1. any age and any party. 2. body mass index between 25 and 35. 3. singleton pregnancy. 4. gestational age of 24 weeks or more. gestational age was established on the basis of menstrual dates and confirmed by first or second trimester ultrasound for booked patients, however, if a difference of \> 7 days or \> 10 days during first or second trimester respectively, then ultrasound value was used. for unbooked patients they still have the chance to be included in our study if they can bring a scan that showed gestational age during the same period mentioned before. 5. idiopathic intrauterine growth restriction. 6. intrauterine growth restriction due to maternal malnutrition, maternal medical disorder as anemia, pregnancy induced hypertension, or chronic renal disease. 7. intrauterine growth restriction due to substance abuse (including smoking). 8. with or without past history of intrauterine growth restriction . exclusion criteria: 1. intrauterine growth restriction due to fetal causes as congenital abnormalities, fetal infection, or multiple gestation. 2. any drug therapy that can affect fetal growth or fetal blood supply. 3. maternal diseases that contraindicates the use of sildenafil citrate